Bone Screws

EUDAMED

Class IIb (EU MDR)

Ref 41513058EModel 4.5mm Cortex screw, self-tappping, full threads, Hex （titianium alloy）,φ4.5×58

by Stryker Trauson (Changzhou) Medical Technology Co., Ltd.

Identity

Trade Name: Bone Screws EUDAMED
Device Name: 4.5mm Cortex screw, self-tappping, full threads, Hex （titianium alloy）,φ4.5×58 EUDAMED
Model / Reference: 4.5mm Cortex screw, self-tappping, full threads, Hex （titianium alloy）,φ4.5×58 EUDAMED
41513058E EUDAMED

Identifiers

Primary DI / UDI-DI: 06931720483313 EUDAMED
Basic UDI-DI: B-06931720483313 EUDAMED
EMDN Code: P09120601 CORTICAL SCREWS EUDAMED

Classification

Device Class: Class IIb EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

Yes

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

Yes

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Bone Screws by Stryker Trauson (Changzhou) Medical Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-06931720483313	Class IIb	Active

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Manufacturer

Manufacturer: Stryker Trauson (Changzhou) Medical Technology Co., Ltd.
EUDAMED SRN: CN-MF-000005689
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

EUDAMED 66da5421-2b4d-48c7-950b-d6441bd35665 61 fields · synced Sep 30, 2026